IVAX Receives Tentative Approval For Gabapentin
November 25 2003 - 11:25AM
UK Regulatory
IVAX Corporation, Miami
David Malina, 305/575-6043
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) has received tentative
approval from the FDA for its Abbreviated New Drug Application (ANDA)
for gabapentin capsules in 100 mg, 300 mg and 400 mg strengths. Upon
final approval this product will be sold through the company's wholly
owned subsidiary, IVAX Pharmaceuticals, Inc. Gabapentin is the generic
equivalent of Neurontin(R), which is used to treat epileptic seizures
and is marketed by Warner-Lambert, a unit of Pfizer, Inc. Neurontin
had U.S. sales of over $2.2 billion during the twelve months ending in
June 2003.
Warner-Lambert sells Neurontin in 5 dosage strengths, 100 mg, 300 mg
and 400 mg capsules and 600 mg and 800 mg tablets. IVAX has also filed
an ANDA for gabapentin tablets in 100 mg, 300 mg, 400 mg, 600 mg and
800 mg dosage strengths and believes that it has first to file status
on gabapentin tablets in 100 mg, 300 mg and 400 mg strengths.
IVAX continues its aggressive program to increase the number of
products in its generic portfolio.
IVAX Corporation, headquartered in Miami, Florida, discovers,
develops, manufactures, and markets branded and brand equivalent
(generic) pharmaceuticals and veterinary products in the U.S. and
internationally.
Copies of this and other news releases may be obtained free of charge
from IVAX' website at http://www.ivax.com.
The "FDA" refers to the United States Food and Drug Administration.
Except for the historical matters contained herein, statements in this
press release are forward-looking and are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of
1995. Investors are cautioned that forward-looking statements involve
risks and uncertainties which may affect the company's business and
prospects, including the risks that final approval of IVAX' ANDA for
gabapentin capsules in 100 mg, 300 mg and 400 mg dosage strengths may
be delayed or not received at all; that launch of the capsules may be
delayed; changing market conditions; the availability and cost of raw
materials and other third party products; the impact of competitive
products and pricing; the difficulty in predicting the timing and
outcome of legal proceedings, including those relating to patent
challenge settlements and patent infringement cases; the difficulty of
predicting the timing of U.S. Food and Drug Administration, or FDA,
approvals; the impact of FDA's or other administrative or judicial
agency's decisions on exclusivity periods; competitors' ability to
extend exclusivity periods past initial patent terms; that IVAX may
not receive approval of its pending ANDA for the 100 mg, 300 mg, 400
mg, 600 mg and 800 mg tablets, or that if approved, the products will
not be successfully commercialized; that IVAX may not be first to file
for the 100 mg, 300 mg, 400 mg tablets; that market acceptance for the
tablet dosage form of gabapentin may not be as anticipated; that IVAX
may not increase the number of products in its generic portfolio; and
other risks and uncertainties based on economic, competitive,
governmental, technological and other factors discussed in the
Company's Annual Report on Form 10-K and its other filings with the
Securities and Exchange Commission. Neurontin(R) is a registered
trademark of Warner-Lambert Company, a unit of Pfizer Inc.